| Primary Device ID | 00389152493671 |
| NIH Device Record Key | 8f46dd41-9812-4026-993a-5b972a21f959 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pharmacy Kit, Starter Pack, Tandem Mobi, Control-IQ+ |
| Version Model Number | 1014936 |
| Company DUNS | 827900809 |
| Company Name | Tandem Diabetes Care, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00389152493671 [Primary] |
| QFG | Alternate Controller Enabled Insulin Infusion Pump |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-21 |
| Device Publish Date | 2025-03-13 |
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| 00389152853772 - Tandem Mobi Autosoft 30 Kit | 2025-12-18 AutoSoft 30, 23"/13mm 10 Pack |
| 00389152854373 - Tandem Mobi TruSteel Kit | 2025-12-18 TruSteel, 23"/6mm 10 Pack |
| 00389152854977 - Tandem Mobi Autosoft XC Kit | 2025-12-18 AutoSoft XC, 5"/6mm 14 Pack |
| 00389152855578 - Tandem Mobi Autosoft XC Kit | 2025-12-18 AutoSoft XC, 23"/6mm 14 Pack |
| 00389152856179 - Tandem Mobi Autosoft 30 Kit | 2025-12-18 AutoSoft 30, 23"/13mm 14 Pack |
| 00389152856971 - Tandem t:slim Autosoft 30 Kit | 2025-12-18 AutoSoft 30, 23"/13 mm 14 Pack |